V. Cathie Stujenske

**** ********* **, ******, ** 38057

acwhze@r.postjobfree.com 901-***-****

PROFESSIONAL SUMMARY

Quality professional with over 25 years of industry experience. Comprehensive background focusing on quality system management, documentation standardization, quality engineering, continuous improvement and employee training in medical device manufacturing.

Comprehensive knowledge of ISO 13485 and 9001 requirements including practical implementation and management experience. Working knowledge of FDA quality system regulation and cGMP for medical devices.

EMPLOYMENT HISTORY

Matrix Machining Technologies, Inc. Memphis, TN Nov 2015-June 2016

Quality Assurance Manager

• Managed the Quality System to ensure compliance with medical device regulations including

ISO 13485 and FDA 21 CFR 820

• Quality Representative during external regulatory body and customer audits

Developed and improved quality documentation including standard operating procedures, work instructions, validation protocols, and inspection plans

Managed Corrective and Preventive Action system

Interacted with customers, vendors and team members concerning quality related issues

Identified and drove continuous improvement initiatives to enhance customer experience, increase efficiency, and standardize processes

Managed change by gaining employee feedback, informing employees, influencing behavior, driving decisions, and setting company policies

Researched new manufacturing and inspection methodologies

Trained and mentored team members

J&B Precision, Inc. Memphis, April 2012-April 2014 and Nov 2014- Nov 2015

Regulatory Manager

• Managed the Quality System to ensure compliance with medical device regulations including

ISO 13485, FDA 21 CFR 820 and ANVISA RDC16-2013

Developed quality documentation including standard operating procedures, work instructions, validation protocols, and inspection plans

Quality Representative during external regulatory body and customer audits

Managed Corrective and Preventive Action system

Interacted with customers, vendors and team members concerning quality related issues

Identified and drove continuous improvement initiatives to enhance customer experience, increase efficiency, and standardize processes

Managed change by gaining employee feedback, informing employees, influencing behavior, driving decisions, and setting company policies

Researched new manufacturing and inspection methodologies

Developed training system and trained and mentored manufacturing team members

Developed gage calibration system

Zimmer, Inc., Memphis, TN April 2014- Nov 2014 Quality Inspector

Performed inspections of purchased parts, subassemblies or finished company products

• Reworked or rejected subassemblies or finished products as required

• Accurately documented the results of the inspections and testing

• Monitored critical equipment and instrumentation to ensure proper operation and

calibration

Performed review of Device History Records and other documentation for compliance to

established procedures and Good Documentation Practices

Smith + Nephew Inc., Memphis, TN Nov 2008 – Dec 2011

Quality Engineering Associate-Gage Design

Collaborated with Quality Control, Product Development, Manufacturing and Supplier Engineers in planning for quality and resolving quality issues

Attended design and print review meetings to discuss dimensional and geometric tolerance methods

Produced and procured final inspection gauging, holding fixtures and overlays for implants and instruments

Performed GR&R studies to ensure proper, reliable, and repeatable gauging

Maintained and revised associated CAD files in product data management software

Mentored and coached individuals and groups for gauging, tolerancing and modeling principles

Participated in the development of a gauge ordering system, providing management with concepts and detailed reports of work in progress

Interacted with outside facilities and vendors regarding gauging issues

Smith + Nephew Inc., Memphis, TN March 1996 – Nov 2008

Quality Engineering Associate I

Supported Quality, Product Development, Manufacturing and Supplier Engineers with new product launch activities for Reconstructive Instrument Team

Created and revised inspection procedures, quality standards and work instructions

Initiated inspection procedure and print changes utilizing computerized change management system

Performed, reviewed and approved first article inspections

Evaluated non-conforming materials for corrective action, analysis and disposition

Instructed Manufacturing Associates in the use of gauges, inspection techniques and product print interpretation

Drove continuous improvement efforts for Instrument Manufacturing Team.

Facilitated Failure, Mode and Effect (FMEA) meetings

Gathered statistical data and provided reject and scrap analysis reports for manufacturing teams

Promoted to Quality Engineering Associate in 1996

Smith + Nephew Inc., Memphis, TN July 1991 – March 1996

Quality Technician I, II, III

Performed first articles and surface plate layouts utilizing various types of inspection equipment such as coordinate measuring machines and optical measuring systems

Calibrated all types of measuring instruments

Participated in process validation studies

Ensured completion and correctness of shop order paperwork

Promoted to Quality Technician II in 1993 and to Quality Technician III in 1995

QUAKER OATS, Dallas, TX July 1988-July 1991

Laboratory Technician

DANA CORPORATION, Lancaster, TX June 1984- July 1988

Machinist

EDUCATION

Southwest Tennessee Community College, Memphis, TN

A.A.S. Mechanical Engineering Technology, 2014

CERTIFICATIONS

Six Sigma Greenbelt Training – Onsite, Smith + Nephew

Manufacturing Fundamentals-Southwest Tennessee Community College

American Society for Quality - Mechanical Inspector, Quality Technician

and Quality Improvement Associate

Geometric Dimensioning and Tolerancing- Jim Meadows Institute

NX Design and Assemblies- Siemens

Screw Machine Set-Up and Operation –Crump Area Vocational and Technical School

Mager Training (Train the Trainer) – Onsite, Smith + Nephew

SKILLS

ISO / FDA Compliance

Standard Operating Procedure / Work Instruction Creation

Corrective and Preventive Action Management

Continuous System and Process Improvement

Change Management

Auditing

Customer / Vendor Communication

Quality Reporting

Equipment Validation - IQ/OQ/PQ

Statistical Process Control

Product Inspection / Blueprint Interpretation / Gauge Calibration / Metrology

Machining

Gauge Development

Geometric Dimensioning and Tolerancing

Mentoring / Coaching / Training

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